18 and older, any sex, with Cardiac Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The Left Ventricular Size (Qualitative Visual Assessment)Primary· Images evaluated by the cardiologists after the acquisition
For each participant, one novice and one expert performed a limited echocardiographic exam on the same patient, so that the quality of each exam could be evaluated by cardiologists. Blinded cardiologists evaluated whether the exam had sufficient image quality to allow visual analysis of left ventricular size. Each exam was independently reviewed by five cardiologists. If at least three cardiologists rated the exam as "Yes" (sufficient quality), the exam was classified as having sufficient image quality; if at least three rated it as "No", the exam was classified as not sufficient. The results
Group
Value
95% CI
Novice With AI Guidance
100
98.4 – 100
Expert Without AI Guidance
100
98.4 – 100
The Left Ventricular Function (Qualitative Visual Assessment)Primary· Images evaluated by the cardiologists after the acquisition
For each participant, one novice and one expert performed a limited echocardiographic exam on the same patient, so that the quality of each exam could be evaluated by cardiologists. Blinded cardiologists evaluated whether the ultrasound examination had sufficient image quality to allow visual analysis of left ventricular function. Each exam was independently reviewed by five cardiologists. If at least three cardiologists rated the exam as "Yes" (sufficient quality), the exam was classified as having sufficient image quality; if at least three rated it as "No", the exam was classified as not su
Group
Value
95% CI
Novice With AI Guidance
100
98.4 – 100
Expert Without AI Guidance
100
98.4 – 100
The Right Ventricle Size (Qualitative Visual Assessment)Primary· Images evaluated by the cardiologists after the acquisition
For each participant, one novice and one expert performed a limited echocardiographic exam on the same patient, so that the quality of each exam could be evaluated by cardiologists. Blinded cardiologists evaluated whether the ultrasound examination had sufficient image quality to allow visual analysis of right ventricular size. Each exam was independently reviewed by five cardiologists. If at least three cardiologists rated the exam as "Yes" (sufficient quality), the exam was classified as having sufficient image quality; if at least three rated it as "No", the exam was classified as not suffi
Group
Value
95% CI
Novice With AI Guidance
100
98.4 – 100
Expert Without AI Guidance
100
98.4 – 100
The Presence of Non-trivial Pericardial Effusion (Qualitative Visual Assessment)Primary· Images evaluated by the cardiologists after the acquisition
For each participant, one novice and one expert performed a limited echocardiographic exam on the same patient, so that the quality of each exam could be evaluated by cardiologists. Blinded cardiologists evaluated whether the ultrasound exam had sufficient image quality to visually analyze the presence of non-trivial pericardial effusion. Each exam was independently reviewed by five cardiologists. If at least three cardiologists rated the exam as 'Yes' (sufficient quality), the exam was classified as having sufficient image quality; if at least three rated it as 'No', the exam was classified a
Group
Value
95% CI
Novice With AI Guidance
100
98.4 – 100
Expert Without AI Guidance
100
98.4 – 100
The Function of the Right Ventricle (Qualitative Visual Assessment)Secondary· Images evaluated by the cardiologists after the acquisition
For each participant, one novice and one expert performed a limited echocardiographic exam on the same patient, so that the quality of each exam could be evaluated by cardiologists. Blinded cardiologists evaluated whether the ultrasound examination had sufficient image quality to allow visual analysis of right ventricular function. Each exam was independently reviewed by five cardiologists. If at least three cardiologists rated the exam as 'Yes' (sufficient quality), the exam was classified as having sufficient image quality; if at least three rated it as 'No', the exam was classified as not s
Group
Value
95% CI
Novice With AI Guidance
99.6
97.7 – 99.9
Expert Without AI Guidance
100
98.4 – 100
The Left Atrium Size (Qualitative Visual Assessment)Secondary· Images evaluated by the cardiologists after the acquisition
For each participant, one novice and one expert performed a limited echocardiographic exam on the same patient, so that the quality of each exam could be evaluated by cardiologists. Blinded cardiologists evaluated whether the ultrasound examination had sufficient image quality to allow visual analysis of left atrium size. Each exam was independently reviewed by five cardiologists. If at least three cardiologists rated the exam as 'Yes' (sufficient quality), the exam was classified as having sufficient image quality; if at least three rated it as 'No', the exam was classified as not sufficient.
Group
Value
95% CI
Novice With AI Guidance
100
98.4 – 100
Expert Without AI Guidance
100
98.4 – 100
The Right Atrium Size (Qualitative Visual Assessment)Secondary· Images evaluated by the cardiologists after the acquisition
For each participant, one novice and one expert performed a limited echocardiographic exam on the same patient, so that the quality of each exam could be evaluated by cardiologists. Blinded cardiologists evaluated whether the ultrasound examination had sufficient image quality to allow visual analysis of right atrium size. Each exam was independently reviewed by five cardiologists. If at least three cardiologists rated the exam as 'Yes' (sufficient quality), the exam was classified as having sufficient image quality; if at least three rated it as 'No', the exam was classified as not sufficient
Group
Value
95% CI
Novice With AI Guidance
98.8
96.4 – 99.6
Expert Without AI Guidance
100
98.4 – 100
The Segmental Kinetics of the Left Ventricle (Qualitative Visual Assessment)Secondary· Images evaluated by the cardiologists after the acquisition
For each participant, one novice and one expert performed a limited echocardiographic exam on the same patient, so that the quality of each exam could be evaluated by cardiologists. Blinded cardiologists evaluated whether the ultrasound examination had sufficient image quality to allow visual analysis of the segmental kinetics of the left ventricle. Each exam was independently reviewed by five cardiologists. If at least three cardiologists rated the exam as 'Yes' (sufficient quality), the exam was classified as having sufficient image quality; if at least three rated it as 'No', the exam was c
Group
Value
95% CI
Novice With AI Guidance
95.4
92.0 – 97.4
Expert Without AI Guidance
100
98.4 – 100
The Aortic Valve (Qualitative Visual Assessment)Secondary· Images evaluated by the cardiologists after the acquisition
For each participant, one novice and one expert performed a limited echocardiographic exam on the same patient, so that the quality of each exam could be evaluated by cardiologists. Blinded cardiologists evaluated whether the ultrasound examination had sufficient image quality to allow visual analysis of the aortic valve. Each exam was independently reviewed by five cardiologists. If at least three cardiologists rated the exam as 'Yes' (sufficient quality), the exam was classified as having sufficient image quality; if at least three rated it as 'No', the exam was classified as not sufficient.
Group
Value
95% CI
Novice With AI Guidance
98.8
96.4 – 99.6
Expert Without AI Guidance
100
98.4 – 100
The Mitral Valve (Qualitative Visual Assessment)Secondary· Images evaluated by the cardiologists after the acquisition
For each participant, one novice and one expert performed a limited echocardiographic exam on the same patient, so that the quality of each exam could be evaluated by cardiologists. Blinded cardiologists evaluated whether the ultrasound examination had sufficient image quality to allow visual analysis of the mitral valve. Each exam was independently reviewed by five cardiologists. If at least three cardiologists rated the exam as 'Yes' (sufficient quality), the exam was classified as having sufficient image quality; if at least three rated it as 'No', the exam was classified as not sufficient.
Group
Value
95% CI
Novice With AI Guidance
100
98.4 – 100
Expert Without AI Guidance
100
98.4 – 100
The Tricuspid Valve (Qualitative Visual Assessment)Secondary· Images evaluated by the cardiologists after the acquisition
For each participant, one novice and one expert performed a limited echocardiographic exam on the same patient, so that the quality of each exam could be evaluated by cardiologists. Blinded cardiologists evaluated whether the ultrasound examination had sufficient image quality to allow visual analysis of the tricuspid valve. Each exam was independently reviewed by five cardiologists. If at least three cardiologists rated the exam as 'Yes' (sufficient quality), the exam was classified as having sufficient image quality; if at least three rated it as 'No', the exam was classified as not sufficie
Group
Value
95% CI
Novice With AI Guidance
95.4
92.0 – 97.4
Expert Without AI Guidance
99.2
97.0 – 99.8
The Size of Inferior Vena Cava (Qualitative Visual Assessment)Secondary· Images evaluated by the cardiologists after the acquisition
For each participant, one novice and one expert performed a limited echocardiographic exam on the same patient, so that the quality of each exam could be evaluated by cardiologists. Blinded cardiologists evaluated whether the ultrasound examination had sufficient image quality to allow visual analysis of the size of the inferior vena cava. Each exam was independently reviewed by five cardiologists. If at least three cardiologists rated the exam as 'Yes' (sufficient quality), the exam was classified as having sufficient image quality; if at least three rated it as 'No', the exam was classified
Group
Value
95% CI
Novice With AI Guidance
78.3
72.7 – 83.1
Expert Without AI Guidance
98.3
95.8 – 99.4
Sponsor's own description
The study's objective is to evaluate if exams, performed with the HeartFocus software by novices, are of sufficient quality to visually analyze the left ventricular size, the left ventricular function, the right ventricular size, and the presence of non-trivial pericardial effusion.
Novices will be nurses without prior ultrasound experience who have received dedicated training on cardiac ultrasound and on Heartfocus software. Ultrasound exams will be limited to the acquisition of 10 reference views
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by DESKi
Last refreshed: 29 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05874128.